Protection apparatus for implantable medical device

• US 7,108,711 B2
• Filed: 04/18/2003
• Issued: 09/19/2006
• Est. Priority Date: 04/26/2001
• Status: Active Grant

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Schulman, Joseph H., Mandell, Lee J., Nelson, Richard J., Falco, Anthony D., Chu, Lung-Hsi, Vogel, Martin J., Firth, Robert A.
• Primary Examiner(s): Pezzuto, Robert E.
• Assistant Examiner(s): Oropeza, Frances P.
• Application Number:
  US10/420,070
• Publication Number:
  US 20030195566A1
• Time in Patent Office: 1,250 Days
• Field of Search: 607/1, 607/36, 206/438, 206/459.1
• US Class Current: 607/1
• CPC Class Codes: A61N 1/14 Leading-off electric charges, e.g. by earthing carrying-off electrostatic charges, in general H05F3/00
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation
• CPC Class Codes: H05K 3/301 by means of a mounting structure H05K3/325 takes precedence
• CPC Class Codes: H05K 3/325 by abutting or pinching, i.e. without alloying process; mechanical auxiliary parts therefor adaptations of leads inserted in holes for press-fit connections H05K3/308

Abstract

A method and apparatus for protecting an electronic implantable medical device prior to it being implanted in a patient'"'"'s body. The apparatus affords protection against electronic component damage due to electrostatic discharge and/or physical damage due to improper handling. The apparatus is comprised of a circuit board having a conductive surface for receiving and releasably grasping the electrodes of the medical device to support the device'"'"'s housing proximate to the surface of the circuit board. Two conductive paths are formed on the circuit board extending between two conductive surfaces for shunting electrostatic discharge currents to prevent such currents from passing through the device'"'"'s electronic circuitry. The conductive paths include oppositely oriented diodes, preferably comprising diodes which emit light (i.e., LEDs) when current passes therethrough. Additionally, an external monitor/generator is provided to enable functional testing of the medical device.

Claims

1. An apparatus for physically and electrically protecting an electronic medical device having first and second electrodes prior to it being implanted in a patient'"'"'s body, said apparatus comprising:

first and second connective surfaces for respectively electrically contacting the first and second electrodes on the medical device;

at least one elastic element for retaining the first and second electrodes of the medical device in physical and electrical contact with said first and second connective surfaces, wherein said at least one elastic element comprises at least one O-ring;

first and second circuit paths connected between said first and second connective surfaces, said first and second circuit paths respectively including oppositely oriented first and second unidirectional current devices to thereby serve to protect the medical device from electrostatic discharge prior to implantation; and

wherein

said apparatus is configured to be separated from the medical device before implantation.

2. The apparatus of claim 1 further including:

a circuit board;

said connective surfaces being formed on said circuit board for contacting the electrodes and supporting the medical device; and

wherein

said first and second circuit paths are formed on said circuit board.

3. The apparatus of claim 2 wherein said circuit board is formed of polyimide.

4. The apparatus of claim 1 wherein said first and second unidirectional current devices comprise light emitting diodes.

5. The apparatus of claim 1 additionally comprising:

a protection network electrically connected across said first and second connective surfaces to suppress electrostatic discharge; and

wherein

said protection network comprises a pair of unidirectional current devices serially connected in opposing polarities.

6. The apparatus of claim 1 additionally comprising a photodiode coupled between said first and second connective surfaces for emitting radiation capable of being remotely sensed corresponding to current flow between the first and second electrodes of the medical device.

7. The apparatus of claim 1 additionally comprising a current loop coupled between said first and second connective surfaces for inductively emitting a field capable of being remotely sensed corresponding to current flow between the first and second electrodes of the medical device.

8. The apparatus of claim 1 wherein said at least one O-ring is formed of medical grade silicone.

9. The apparatus of claim 1 wherein said at least one elastic element comprises a single O-ring.

10. The apparatus of claim 9 further comprising:

a circuit board, wherein said circuit board includes a pair of retaining lips for capturing said single O-ring; and

wherein

said medical device is retainable between said O-ring and said circuit board.

11. In combination with a medical device configured to be implanted in a patient'"'"'s body, the device including a housing containing electronic circuitry connected to first and second electrodes extending exteriorly from the housing, an apparatus for use with the medical device prior to it being implanted, said apparatus comprising:

a dielectric substrate carrying spaced first and second connective surfaces, each of said connective surfaces being configured to electrically contact one of the electrodes of the medical device;

at least one elastic element for retaining the first and second electrodes of the medical device in physical and electrical contact with said first and second connective surfaces, wherein said at least one elastic element comprises at least one O-ring;

a first shunt circuit carried by said substrate electrically connected between said first and second connective surfaces;

a second shunt circuit carried by said substrate electrically connected between said first and second connective surfaces;

wherein

said first and second shunt circuits respectively include oppositely directed first and second diodes to thereby serve to protect the medical device from electrostatic discharge prior to implantation to thereby serve to protect the medical device from electrostatic discharge prior to implantation; and

wherein

said apparatus is configured to be separated from the medical device before implantation.

12. The apparatus of claim 11 wherein said dielectric substrate is a circuit board formed of polyimide.

13. The apparatus of claim 11 wherein said first and second diodes each include means for emitting light in response to current therethrough.

14. The apparatus of claim 13 further including an external monitor for externally sensing the response of said diodes to an externally provided activation signal supplied to the electronic circuitry.

15. The apparatus of claim 14 wherein said externally provided activation signal is wirelessly supplied to the electronic circuitry within the medical device.

16. The apparatus of claim 13 additionally comprising:

a shipping container defining a transparent window; and

wherein

said apparatus is accommodated in said shipping container with said diodes visible through said window.

17. The apparatus of claim 11 additionally comprising:

a protection network electrically connected across said first and second connective surfaces to suppress electrostatic discharge; and

wherein

said protection network comprises a pair of unidirectional current devices serially connected in opposing polarities.

18. The apparatus of claim 11 additionally comprising a photodiode coupled between said first and second connective surfaces for emitting radiation capable of being remotely sensed corresponding to current flow between the first and second electrodes of the medical device.

19. The apparatus of claim 11 additionally comprising a current loop coupled between said first and second connective surfaces for inductively emitting a field capable of being remotely sensed corresponding to current flow between the first and second electrodes of the medical device.

20. The apparatus of claim 11 wherein said dielectric substrate includes a cutout located within said current loop to enable an externally provided inductive pickup loop to pass through said current loop and to inductively pick up a signal corresponding to current flow between the first and second electrodes of the medical device.

21. The apparatus of claim 11 wherein said at least one O-ring is formed of medical grade silicone.

22. The apparatus of claim 11 wherein said at least one elastic element comprises a single O-ring.

23. The apparatus of claim 22 wherein said dielectric substrate is a circuit board that includes a pair of retaining lips for capturing said single O-ring and wherein the medical device is retainable between said O-ring and said circuit board.

24. A method of protecting an implantable medical device prior to implantation, the device comprising a housing containing electronic circuitry connected between first and second electrodes extending exteriorly from the housing, said method comprising:

providing first and second contacts for electrically contacting the first and second electrodes;

providing at least one elastic element comprising at least one O-ring, for retaining the first and second electrodes of the medical device in physical and electrical contact with said first and second contacts;

providing a first shunt path between said first and second contacts including a first current device oriented to permit current therethrough only from said first to said second contact; and

providing a second shunt path between said first and second contacts including a second current device oriented to permit current therethrough only from said second to said first contact, whereby said first and second shunt paths serve to protect the medical device from electrostatic discharge prior to implantation to thereby serve to protect the medical device from electrostatic discharge prior to implantation; and

wherein

said apparatus is configured to be separated from the medical device before implantation.

25. The method of claim 24 additionally comprising the steps of:

providing a substantially rigid substrate for supporting said first and second contacts, said first shunt path, and said second shunt path; and

configuring said first and second contacts for physically retaining the housing relative to said substrate.

26. The method of claim 24 additionally comprising the step of providing an indicator in at least one of said shunt paths to indicate current therethrough.

27. The method of claim 24 additionally comprising the steps of:

emitting light in said first shunt path to indicate current therethrough; and

emitting light in said second shunt path to indicate current therethrough.

28. The method of claim 27 further including:

providing a shipping container defining a transparent window; and

placing the device in said shipping container oriented so that light emissions from said first and second shunt paths are visible through said window.

29. The method of claim 28 further including sterilizing the device while in said shipping container.

30. The method of claim 28 further including:

applying an activation signal to the device while in said shipping container; and

monitoring the light emissions from said shunt paths in response to the application of said activation signal.

31. The method of claim 30 wherein said step of applying an activation signal comprises providing wirelessly communicating energy to the electronic circuitry in the housing.